During an inspection of your firm, FSC Laboratories, Inc. (FSC), conducted at 6000 Fairview Road, Suite 600, in Charlotte, NC on March 14-17, 2011, an investigator from the U. S. Food and Drug Administration (FDA) determined that your firm is a specification developer that holds a 510(k) application for the E-Z Spacer®, an inhalation device. This product is a device within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 321(h)] in that it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.

This inspection revealed that this device is adulterated within the meaning of Section 501(h) of the Act [21 U.S.C. § 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found in Title 21 of the Code of Federal Regulations (CFR), Part 820 (21 CFR Part 820). We received a response from Karla Worley Ham, FSC Regulatory Affairs Officer, dated April 5, 2011, concerning our investigator's observations noted on the FORM FDA 483, Inspectional Observations, issued to her at the close of the inspection. We address this response below, in relation to the noted violations. The violations include, but are not limited to, the following:

1. Your firm failed to establish procedures that define the interval and frequency at which management with executive responsibility shall review the suitability and effectiveness of the quality system, as required by 21 CFR Part 820.20(c). Specifically, your firm has not established procedures for management review and no management reviews have been conducted.

Your response to this observation appears to be adequate. However, review of your management review agenda dated 3/31/11, does not indicate that the discussion of new product introductions requiring revisions to the current quality system occurred. Your standard operating procedure (SOP) for management review, SOP-020, indicates that this input will be discussed during the management reviews. This inspection revealed that your firm is a virtual company that specializes in the acquiring, developing, and marketing of medical devices and drugs; therefore, it is our expectation that the discussion of new products would be included on your management review agenda and the discussion documented.

2. Your firm's management with executive responsibility failed to establish its policy and objectives for, and commitment to, quality and ensure that it is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20(a). Our inspection revealed that no quality policy has been established by your firm and communicated to your personnel.

Your response to this observation appears to be adequate; however, your corporate quality policy procedure does not explicitly indicate whether the policy training will be documented in each employee's training file. Because the majority of your employees are located outside of the inspected corporate location, it is our expectation you will maintain quality policy training documentation that will be accessible during subsequent FDA establishment inspections.

3. Your firm failed to establish a quality plan defining the quality practices, resources, and activities relevant to devices that are designed and manufactured, as required by 21 CFR 820.20(d).Specifically, your firm has not established a quality agreement with the contract manufacturer of the EZ Spacer nebulizer devices. The responsibilities between FCS and the contractor have not been clearly defined. Additionally, a similar observation was made regarding your failure to establish a quality agreement with your contract manufacturer of the drug, (b)(4).

Your response to this observation appears to be adequate. Your quality plan indicates that all product release testing will be conducted by your contactor. It is our expectation that you are aware that as the owner of the device, which is labeled as marketed by your firm, you are ultimately responsible for the manufacture, release, and distribution of this product.

4. Your firm failed to adequately document corrective and preventive action activities and their results, as required by 21 CFR 820.100(b). For example, at least 12 complaints on the EZ Spacer have been documented since 2008 for distorted handles, difficulty in opening, and broken devices. Additionally, EZ Spacer product design and tooling quality issues have been documented by your firm. Continued quality issues have been reported and our investigator observed correspondence from your contractor, attached to each complaint reviewed, indicating the need for device design changes. Corrective and preventative measures have not been adequately addressed, documented, or implemented by your firm.

Your response to this observation appears to be adequate. Your commitment to device redesign and any new 510(k) submission will be monitored and evaluated during a subsequent FDA establishment inspection.

5. Your firm failed to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.198(c). Specifically, your firm did not provide quarterly complaint summaries to each manufacturer of FSC products as specified in your complaint procedures, SOP-006. Your firm did not perform any complaint trending during management review and input, and verify that no additional corrective action is necessary.

We have reviewed your response and have concluded that it is partially inadequate in that it does not address or give an indication that the quarterly complaint summaries were subsequently provided to each manufacturer of FSC Laboratories' products. Also, while the planned SOP revisions noted in your response appear to be adequate, you did not submit the updated written SOPs with your response. Your response stated that the revisions would be completed by June 30, 2011. Your SOPs will be evaluated during a subsequent FDA establishment inspection.

You should take prompt action to correct the violations addressed in this letter and noted on the FORM FDA 483 issued at the closeout of the inspection. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all warning letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the quality system regulation deviations are reasonably related, will not be approved until the violations have been corrected. Requests for certificates to foreign governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar ones, from occurring again. Include documentation of corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

This letter is not intended to be an all-inclusive list of the violations at your firm. It is your responsibility to ensure compliance with applicable laws and regulations administered by the FDA. The specific violations noted in this letter and in the FORM FDA 483, Inspectional Observations, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, 60-8th Street NE, Atlanta, GA 30309. If you have any questions, please contact Mrs. Morton at 404·253-1285.